Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 270-728-3 | CAS number: 68477-39-4 A complex combination of hydrocarbons obtained by distilling cracked stripped steam-cracked distillates. It consists of hydrocarbons having carbon numbers in the range of C8 through C10 and boiling in the range of approximately 129°C to 194°C (264°F to 382°F).
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
Endpoint summary
Administrative data
Description of key information
Key value for chemical safety assessment
Skin sensitisation
Link to relevant study records
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: GLP compliant, guideline study, available as unpublished report, restrictions in design and reporting but otherwise adequate for assessment
- Qualifier:
- according to guideline
- Guideline:
- EPA OTS 798.4100 (Skin Sensitisation)
- Deviations:
- yes
- Remarks:
- only 10 animals in test group
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- Buehler test
- Justification for non-LLNA method:
- Acceptable study that followed sound scientific principles.
- Species:
- guinea pig
- Strain:
- Hartley
- Sex:
- male
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Sasco, Inc., Omaha, Nebraska, USA.
- Age at study initiation: Young adult
- Weight at study initiation: 300-500 g
- Housing: Individually in stainless steel, wire mesh bottom cages.
- Diet: Fresh Agway Certified Guinea Pig Feed ad libitum
- Water: ad libitum
- Acclimation period: 7-14 days
ENVIRONMENTAL CONDITIONS
- Temperature: 64-79°F
- Humidity: 40-70%
- Air changes: At least 10/hour
- Photoperiod: 12hrs dark / 12hrs light
IN-LIFE DATES: From: 7 February 1990 To: 16 March 1990 - Route:
- epicutaneous, occlusive
- Vehicle:
- other: mineral oil
- Concentration / amount:
- Induction: 1:2 v/v dilution,
Challenge: 1:4 v/v dilution - Route:
- epicutaneous, occlusive
- Vehicle:
- other: mineral oil
- Concentration / amount:
- Induction: 1:2 v/v dilution,
Challenge: 1:4 v/v dilution - No. of animals per dose:
- 10 test, 10 vehicle control, 10 positive control (plus 4/group challenge control)
- Details on study design:
- RANGE FINDING TESTS: 6 guinea pigs exposed to neat, 1:2, 1:4 and 1:8 v/v dilutions in mineral oil. 0.5 mL applied for 6 hours and irritation assessed using the Draize scoring system approximately 24 and 48 hours after treatment. No irritation was seen at the 24 hour reading. At the 48 hour reading erythema and oedema were present at the neat site, oedema was present at the 1:2 dilution site and no signs of irritation were seen at the 1:4 and 1:8 v/v dilution sites. Dilutions of 1:2 and 1:4 for the induction and challenge applications, respectively, were selected for use in the main study.
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 3
- Exposure period: 6 hours, once per week
- Test groups: 0.5 mL of a 1:2 v/v dilution of E000144700 in mineral oil
- Control group: 0.5 mL of mineral oil
- Site: shaved dorsal area
B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: 14 days after last induction application
- Exposure period: 6 hours
- Test groups: 0.5 mL of a 1:4 v/v dilution of E000144700 in mineral oil
- Control group: 0.5 mL of a 1:4 v/v dilution of E000144700 in mineral oil
- Site: naive site on the shaved dorsal area
- Evaluation (hr after challenge): 24 and 48 hours - Challenge controls:
- Unused naive guinea pigs were used to distinguish between "background" irritation and actual allergic response (4 guinea pigs for each group-test, vehicle control and positive control)
- Positive control substance(s):
- yes
- Remarks:
- dinitrochlorobenzene
- Positive control results:
- Following induction (x3) with 0.3% DNCB, challenge with 0.2% DNCB resulted in significantly higher response than that observed in the naive challenge control group.
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 1:4 v/v dilution
- No. with + reactions:
- 0
- Total no. in group:
- 9
- Clinical observations:
- no response
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 1:4 v/v dilution . No with. + reactions: 0.0. Total no. in groups: 9.0. Clinical observations: no response.
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 1:4 v/v dilution
- No. with + reactions:
- 0
- Total no. in group:
- 9
- Clinical observations:
- no response
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 1:4 v/v dilution . No with. + reactions: 0.0. Total no. in groups: 9.0. Clinical observations: no response.
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 1:4 v/v dilution
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- no response
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 1:4 v/v dilution . No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: no response.
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 1:4 v/v dilution
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- no response
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 1:4 v/v dilution . No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: no response.
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- positive control
- Dose level:
- 0.2%
- No. with + reactions:
- 10
- Total no. in group:
- 10
- Clinical observations:
- erythema scores of 1 or 2 in all animals
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: positive control. Dose level: 0.2% . No with. + reactions: 10.0. Total no. in groups: 10.0. Clinical observations: erythema scores of 1 or 2 in all animals.
- Interpretation of results:
- other: Not sensitising
- Conclusions:
- Under the conditions of the study described, E000144700 was not a delayed contact sensitiser.
- Executive summary:
The sensitization potential of E00014470 (CAS 68516-20-1) was investigated in male guinea pigs dermally exposed to a 1:2 v/v dilution of 0.5 mL E000144700 in mineral oil for each of 3 induction phases. Following challenge with a 1:4 dilution response grades, severity and incidence were not greater than those at the control group site. The positive control, DNCB, produced significantly higher responses than in the control group which were free of dermal lesions throughout the study period.
It is concluded that E000144700 (CAS 68516-20-1) is not a skin sensitiser and no classification is warranted under Dir 67/548/EEC or GHS/CLP.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
Skin sensitisation
Non-human information
In a study using methodology based on Buehler, the sensitization potential of CAS 68516-20-1 was investigated in groups of 10 male guinea pigs dermally exposed to a 1:2 v/v dilution of 0.5 mL in mineral oil for each of 3 induction phases. Following challenge with a 1:4 dilution response grades, severity and incidence were not greater than those at the control group site. It was concluded that CAS 68516-20-1 was not a skin sensitiser.
A maximisation test in accordance with EU guideline B6 (Skin sensitisation) was performed by NOTOX (1996) to assess the sensitisation potential of toluene in guinea pigs. A grade 1 reaction (discrete or patchy erythema) was seen in 1/20 tested animals in response to challenge with a 50% solution. No other skin reactions were observed. It was concluded that toluene was not a skin sensitiser in this study.
Human information
There are no reports of skin sensitisation in humans attributed to low benzene naphtha streams or toluene NOTOX (1996). Assessment of contact hypersensitivity to toluene in the albino guinea pig (Maximization test). Testing laboratory: NOTOX, s'Hertogenbosch, The Netherlands. Report no.: 179911. Owner company: Shell. Report date: 1996-11-21.
Migrated from Short description of key information:
The available animal data are sufficient to conclude that members of the low benzene naphtha category are not skin sensitisers. Toluene is not a skin sensitiser in animals and there are no reports of skin sensitisation attributed to toluene in humans.
Justification for selection of skin sensitisation endpoint:
Data for representative streams, together with information on the key marker substance toluene, indicate that members of this category will not cause skin sensitisation.
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
- Additional information:
No animal or human data have been found with regard to respiratory sensitisation of low benzene naphtha streams or of the specific component, toluene.
Migrated from Short description of key information:
There are no data on respiratory sensitisation for the low benzene naphtha streams or toluene, but there is no evidence that they require classification for sensitisation properties.
Justification for classification or non-classification
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.